List of approved devices cdsco

List of approved devices cdsco. OF INDIA Notice: Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Directorate General of Health Services, Government of India FDA Bhavan, ITO, Kotla Road, New Delhi -110002; dci[at]nic[dot]in; 91-11-23236973; PRO Toll Free No. After 30 September 2022, all Class A & B Medical Devices become notified medical devices & after 30 September 2023, all Class C & D Medical devices will become notified medical devices. xlsx Author: MD-04-2019 Created Date: 9/13/2021 6:21:24 PM 72 North Zone Haryana M/s Mankind Research Centre, Mankind Pharma Ltd. of India Central Drugs Standard Control Organization (Medical Devices Division) Medical Devices Frequently Asked Questions Doc No. The list identifies which device types each particular MDTL is qualified to test, so manufacturers seeking to register their products 1 day ago · What's New Vacancy for post of Director in RDTL Chandigarh Vacancy for Deputy Director in RDTL Guwahati Vacancy for Senior Assistant (Admn) in CDSCO Number of Cough syrup sample for Export at Different Laboratories for testing Regulation of all Class A & B Medical Devices under Licensing regime, w. What's New Vacancy for post of Director in RDTL Chandigarh Vacancy for Deputy Director in RDTL Guwahati Vacancy for Senior Assistant (Admn) in CDSCO Number of Cough syrup sample for Export at Different Laboratories for testing Regulation of all Class A & B Medical Devices under Licensing regime, w. 2020 GSR 754 (E) 30-09-2022 Sale of Medical Device Subject: List of Notified Bodies registered with CDSCO under MDR, 2017- regarding As you are aware that Medical Device Rules 2017 has already been published vide G. , Plot No. All remaining Class C and D devices not already Notified will need to have Import Licenses by October 1, 2023. Ahmedabad City,Ahmedabad City,Gujarat What's New Notice regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency use listing 15th April,2021 DCGI Message 202101 Jan 2021 For Medical devices which are under voluntary registrations, the file number generated is the What's New Notice regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency use listing 15th April,2021 DCGI Message 202101 Jan 2021 For Medical devices which are under voluntary registrations, the file number generated is the The Central Drugs Standard Control Organization (CDSCO), India’s medical device market regulator, has now identified 24 total MDTLs to provide testing and evaluation according to the Medical Device Rules, 2017. Medical Devices Rules 2017 has already been published vide G. The CDSCO fees for application processing depends on the device classification. K: 2018-Aug-30: 72 KB: 381 list of new drugs approved 2014: 2017-feb-27: 527 kb: 15: list of new drugs approved 2013: 2017-feb-26: 244 kb: 16: list of new drugs approved 2012: 2017-feb-25: 140 kb: 17: list of new drugs approved 2010: 2017-feb-24: 455 kb: 18: list of new drugs approved 2011: 2017-feb-24: 427 kb: 19: 2 list of new drugs approved 2008: 2017-feb-23: 80 kb list of new drugs approved 2015: 2017-feb-28: 348 kb: 14: list of new drugs approved 2014: 2017-feb-27: 527 kb: 15: list of new drugs approved 2013: 2017-feb-26: 244 kb: 16: list of new drugs approved 2012: 2017-feb-25: 140 kb: 17: list of new drugs approved 2010: 2017-feb-24: 455 kb: 18: list of new drugs approved 2011: 2017-feb-24: 427 kb: 19 GUIDELINES ON APPROVAL OF CLINICAL TRIAL & NEW DRUGS Effective Date: Page 4 of 71 DRAFT GUIDANCE ON APPROVAL OF CLINICAL TRIAL & NEW DRUG 3 BACKGROUND Demonstration of safety and efficacy of the drug product for use in Central Drugs Standard Control Organization (Medical Devices and Diagnostic Division) Medical Devices (MD) Frequently Asked Questions on Medical Device Rule, 2017 Doc No. This device is reusable after sterilization. OF INDIA Notice: NOC update list of Medical Devices 2014: 2018-Oct-10: 79 KB: 117: NOC update list of Medical Devices 2017: 2018-Oct-10: 914 KB: 118: NOC update list of Medical Devices 2018: 2018-Oct-10: 225 KB: 119: NOC update list of Medical Devices 2015: 2018-Oct-10: 162 KB: 120: NOC update list of Medical Devices 2016: 2018-Oct-10: 138 KB: 121: NOC update COPPs granted by CDSCO for Ayurvedic Products; List of FDC & Subsequent New Drugs Approved For Marketing in India; List of Approved New Drugs; Veterinary Drugs & Vaccines Approved by CDSCO from January 2020 to September 2022; List of Veterinary Drugs; List of Veterinary Vaccine and Drugs Approved by CDSCO from 2010 to 2019 CDSCO updated list of Laboratories for conducting Performance Evaluation of In - Vitro Diagnostic Medical Device Sr. The updated list of medical devices testing laboratories registered with CDSCO What's New Notice regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency use listing 15th April,2021 DCGI Message 202101 Jan 2021 For Medical devices which are under voluntary registrations, the file number generated is the 2017). The new Medical Device Rules, 2017 significantly expands the number of IVD devices requiring full technical documentation in support of their registration applications. 2023: 2023-Sep-29: 654 KB: 4 Jan 1, 2021 · What's New Notice regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency use listing 15th April,2021 DCGI Message 202101 Jan 2021 For Medical devices which are under voluntary registrations, the file number generated is the What's New Notice regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency use listing 15th April,2021 DCGI Message 202101 Jan 2021 For Medical devices which are under voluntary registrations, the file number generated is the What's New Notice regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency use listing 15th April,2021 DCGI Message 202101 Jan 2021 For Medical devices which are under voluntary registrations, the file number generated is the 4 days ago · What's New Vacancy for post of Director in RDTL Chandigarh Vacancy for Deputy Director in RDTL Guwahati Vacancy for Senior Assistant (Admn) in CDSCO Number of Cough syrup sample for Export at Different Laboratories for testing Regulation of all Class A & B Medical Devices under Licensing regime, w. The certification process involves a thorough review of the device’s design, manufacturing processes, and performance data. R. 1800 11 1454 Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. 09. 1800 11 1454 (Medical Devices and Diagnostics Division) NOTICE Dated: 2 7 2021 Subject: List of medical devices testing laboratory (MDTL) for carry out test or evaluation of medical device on behalf of manufacturer registered with CDSCO under MOR 2017- reg. There are some low-risk categories like software, dermatology and rehabilitation that do not have any Class D medical devices and also there are some high-risk categories like radiotherapy that do What's New Notice regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency use listing 15th April,2021 DCGI Message 202101 Jan 2021 For Medical devices which are under voluntary registrations, the file number generated is the Central Drugs Standard Control Organization (CDSCO) FDA Bhavan, Kotla Road, ITO, Mandi House New Delhi - 110 002 91-11-23216367(CDSCO)/ 23236975 ithelpdeskcdscoMD[at]gmail[dot]com 3 days ago · CDSCO Latest Updates: Find out the latest news and information about the Central Drugs Standard Control Organisation, the national regulatory authority of India for drugs, cosmetics, medical devices and diagnostics. Used to eliminate water and cutting debris that have accumulated in the oral cavity. 2023: 2023-Sep-29: 654 KB: 4 Central Drugs Standard Control Organization (CDSCO) FDA Bhavan, Kotla Road, ITO, Mandi House New Delhi - 110 002 91-11-23216367(CDSCO)/ 23236975 ithelpdeskcdscoMD[at]gmail[dot]com Renaming of Central Drugs Standard Control Organization dated 06. 134, Industrial Area, Phase-I, Panchkula. A-32, COPPs granted by CDSCO for Ayurvedic Products; List of FDC & Subsequent New Drugs Approved For Marketing in India; List of Approved New Drugs; Veterinary Drugs & Vaccines Approved by CDSCO from January 2020 to September 2022; List of Veterinary Drugs; List of Veterinary Vaccine and Drugs Approved by CDSCO from 2010 to 2019 Apr 13, 2024 · New Delhi, 13 April 2024: The Central Drugs Standard Control Organisation (CDSCO) has released the draft guidance document on Good Distribution Practices (GDP) for pharmaceutical products, in line with Which division of CDSCO is responsible for review of IVD kits/ reagents ? Ans: Medical Devices & Diagnostics Division, Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, FDA Bhavan, ITO, Kotla Road, New Delhi -110002. Surgical Dressings – Dressing pad, non-sterilized 6. Formerly only the critical IVD devices required registration with Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Directorate General of Health Services, Government of India FDA Bhavan, ITO, Kotla Road, New Delhi -110002; dci[at]nic[dot]in; 91-11-23236973; PRO Toll Free No. Firms can request to test vaccine samples at CDL Kasauli and receive batch release certificate online. Manufacturer Click to view manufacturer details. Dec 20, 2019 · Dear MedTech developers, CDSCO has published the list of 21,277 Approved Devices so far in India. These devices require a more rigorous premarket review than the 510(k What's New Notice regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency use listing 15th April,2021 DCGI Message 202101 Jan 2021 For Medical devices which are under voluntary registrations, the file number generated is the Apr 28, 2023 · This is the comprehensive list of the devices classified into four classes and notified by CDSCO in furtherance of the Medical Devices Rules of 2017. List of Medical Devices along with undertaking in prescribed pro-forma as per Annexure VII. Designed, Developed and List Of Approved Devices. Government of India Overview on Performance Evaluation / External Evaluation of In vitro Diagnostic Medical Device (IVDMD) Draft for Public Comment 2022 Central Drugs Standard Control Organization test or evaluation of a medical device on behalf of the manufacturer (Form MD-40 of MDR, 2017). Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Directorate General of Health Services, Government of India FDA Bhavan, ITO, Kotla Road, New Delhi -110002; dci[at]nic[dot]in; 91-11-23236973; PRO Toll Free No. 3800026. 2018 Nova Medical Devices 6/7 Maruti Industrial Estate , Nr. 2021 under the provisions of the Medical Device Rules, 2017 (Form MD-40 enclosed). This transition is effective from October 1, 2023. 2017 to carry out test or evaluation of a medical device on behalf of manufacturer is given below & there are more applicants which are under evaluation. Medical device CDSCO certification obtain to the process by which medical devices and IVDs are evaluated and approved for use in India. Sep 27, 2023 · CDSCO has issued a list of 60 Rehabilitation medical devices like Exothermic heat therapy packs, Bicycle ergometers, Bed/chair electric massagers, Acupressure calf bands, etc. Plaster of Paris Bandage, non Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Directorate General of Health Services, Government of India FDA Bhavan, ITO, Kotla Road, New Delhi -110002; dci[at]nic[dot]in; 91-11-23236973; PRO Toll Free No. List Of Approved Devices. 23: 2023-Dec-06: 654 KB: 2: Updation of classification in IVD medical devices under the provision of MD Rules 2017: 2023-Oct-25: 1473 KB: 3: CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated 26. As you are aware that Medical Devices Rules 2017 has already been published vide What's New Notice regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency use listing 15th April,2021 DCGI Message 202101 Jan 2021 For Medical devices which are under voluntary registrations, the file number generated is the CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated 29. Step 4 Pay the application fee. 1800 11 1454 Directorate General Of Health Services Ministry of Health & Family Welfare, Government of India Apr 23, 2021 · Notified Devices: There are 37 categories of devices listed in Notified list, which are regulated by the CDSCO and require prior approval from the CDSCO for marketing them in India. All these devices require a CDSCO license to manufacture or import. Promotional literature, package insert, device labels etc 14. Sidhawai Mata Mandir,Ramol Road , Ctm Crooss Road. It is responsible for overseeing the import, manufacture, sale, and distribution of medical devices in the country. As of October 1, 2021, all medical devices will need to be at least Registered with the CDSCO while specific product categories, called Notified Devices, will need to obtain an Import License prior to importation. (Only applicable for devices that Aug 25, 2023 · The Central Drugs Standard Control Organization (CDSCO) has introduced changes to the regulatory Sr. : CDSCO/FAQ/MD/01/2024 Notice: Online process for Biologicals(Vaccines & r-DNA) is available on SUGAM. Ahmedabad. 78 (E) dated 31 01. ISO 13485:2003 Certificate (if any) 15. : CDSCO/FAQ/MD/01/2018 CENTRAL DRUGS STANDARD CONTROL ORGANIZATION DIRECTORATE GENERAL OF HEALTH SERVICES MINISTRY OF HEALTH & FAMILY WELFARE GOVT. List of FDC & Subsequent New Drugs Approved in India. Registrations of Non-Notified devices do not currently require the identification of predicate devices to register. List of CDSCO Approved Medical Devices for Testing or Evaluation. This list also includes any other instrument not expressly stated in the list but intended for diagnostic purposes. The CDSCO ensures that medical devices comply with safety, quality, and efficacy standards. A 28 Dental suction system cannula, single-use A tubal dental device to be connected to a non-active Determine the classification of your device according to the CDSCO’s published classification lists. 11. Here is the link - https://cdscomdonline. 73 North Zone Haryana M/s Omega Test House, Plot No. 01. Medical devices are classified into 5 categories; A (non-Measuring/Sterile), A (Measuring/Sterile) B, C, and D based on risk level. 10. The updated list of medical devices testing laboratories registered with CDSCO under the provisions of Medical Devices Rules, 2017 to carry out test or evaluation of a Indian authorities overhauled the medical device regulatory process in 2017 with the publication of the Medical Device Rules. 102(E) dt 11. No. 2020 GSR 754 (E) 30-09-2022 Sale of Medical Device Sep 26, 2023 · Non-Notified Medical Devices: These devices do not need CDSCO’s approval and can be sold without specific regulatory checks. 12. The registration process will generate a file number the same day and must be included on the label prior to marketing. Explore the online portal Sugam, the list of approved new drugs, and more. Showing 1 to 10 of 37 entries. of India Page 6 of 211 (zh) “new in vitro diagnostic medical device” means any medical device as referred to in sub-clause (A) of clause (zb) used for in vitro diagnosis that has What's New Notice regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency use listing 15th April,2021 DCGI Message 202101 Jan 2021 For Medical devices which are under voluntary registrations, the file number generated is the Nov 29, 2023 · Annexure B for IVD instruments – now contains 29 medical devices, all of which are classified as class A (see below). 2019-Jan-02. Public Respirator (2 ply, 3 ply face mask), non-sterilized 3. IMDR was amended in February 2020 as “Medical Devices (Amendment) Rules, 2020”and came into force in April 2020. 1800 11 1454 Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Directorate General of Health Services, Government of India FDA Bhavan, ITO, Kotla Road, New Delhi -110002; dci[at]nic[dot]in; 91-11-23236973; PRO Toll Free No. e. Step 3 Prepare the device application and supporting documents for submission to the CDSCO. Manufacturers can add their Formulations Data on SUGAM Portal. The notification included a number of annexes, one of which included a list of the FDCs that the Indian government had approved "in a phase-wise manner based on phased scrutiny and recommendations by Kokate Committee," the group established to judge the efficacy of medication combinations Mar 20, 2023 · Central Drugs Standard Control Organization (CDSCO) 1940. Two additional lists were also added to the Medical Device Rules, 2017: Annexure D for IVD Specifmen Receptacles What's New Notice regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency use listing 15th April,2021 DCGI Message 202101 Jan 2021 For Medical devices which are under voluntary registrations, the file number generated is the Jul 12, 2021 · Medical Devices and Diagnostics Division of Central Drug Standard Control Organisation (CDSCO) has developed structured regulations for medical devices, IMDR which was released in January 2017 and came into force from January 2018. CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated 29. Import Click to view import details. 1. 2018. Apr 17, 2023 · A report on CDSCO's examination of FDCs, which has been ongoing for ten years, was released in February. 1800 11 1454 Nov 9, 2020 · The Central Drugs Standard Control Organisation (CDSCO) has released two notices on September 3, 2020, including the classification of non-notified medical devices and in-vitro diagnostic devices (IVDs). framework for Class C and Class D (non-notified) medical devices. 3 List of medical devices (CDSCO): Oct 27, 2021 · Based on the provisions of the Medical Device Rules (MDR) -2017, the Drug Controller General of India (DCGI) has issued a classification of in-vitro diagnostic (IVD) medical devices used in various clinical fieldson 23 July 2021. 2023: 2023-Sep-29: 654 KB: 4 Act & Rules and Medical Devices Rules -2017, respective Guidelines / Clarifications issued by CDSCO time to time for all their professional needs. Jul 29, 2021 · Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules related to that. f 01. Jun 22, 2018 · The updated list of medical devices testing laboratories registered with CDSCO up till under rule 81 in the provisions of Medical Devices Rules. R 78(E) dated 31. Medical devices submitted under the new voluntary rules are referred to as “Non-Regulatory Medical Devices”. he Central Drugs Standard Control Organisation (CDSCO)under Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India is the National Regulatory Authority (NRA) of India. Analytical & Statistical Platforms. 2016 CDSCO What's New Notice regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency use listing 15th April,2021 DCGI Message 202101 Jan 2021 For Medical devices which are under voluntary registrations, the file number generated is the 2017). 191-E, Sector-4-II, IMT Manesar, Distt. 2022, as per G. 12. Click here to Apply/Check status of the Applications. The rules came into force in January 2018 and devices are regulated by the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare. 318 KB. Consumer Forms For Medical Devices. The Central Drugs Standard Control Organization (CDSCO) is the primary regulatory body for medical devices in India. Designed, Developed and Maintained by List of medical devices testing laboratory (MDTL) for carry out test or evaluation of medical device on behalf of manufacturer registered with CDSCO under MDR 2017 2023-Sep-15 1635 KB LIST OF NEW DRUGS APPROVED FROM 01-01-2018 to 31. In-Vitro Diagnostic Reagents/ Kits for detection for HIV 1) National Institute of Biologicals, Plot No. There are 18 MDTLs have been registered with CDSCO till dated 07. 2018 : 2018-Sep-07: 496 KB: 380: Faulty ASR Hip Implant Manufactured by M/s DePuy International Limited U. 11. Surgical caps 7. There are 18 MDTLs have been registered with CDSCO till dated 07M2. 6. Approved Devices; MD. Transition Summary. government has approved the creation of four medical . 3 days ago · What's New Vacancy for post of Director in RDTL Chandigarh Vacancy for Deputy Director in RDTL Guwahati Vacancy for Senior Assistant (Admn) in CDSCO Number of Cough syrup sample for Export at Different Laboratories for testing Regulation of all Class A & B Medical Devices under Licensing regime, w. Elasticated Cohesive Bandage, non-sterilized 5. 10. Updated list of Laboratories for conducting Performance Evaluation of In - Vitro Diagnostic Medical Device Sr. Nov 29, 2023 · IVD product registration in India is overseen by the Central Drugs Standard Control Organization (CDSCO). Category of In vitro Diagnostics Medical Devices Name of Testing facility 1. 2016 Directorate General Of Health Services Ministry of Health & Family Welfare, Government of India A tubal dental device to be connected to a non-active aspiration device (usually, a dentistry dedicated device). S. (Only applicable for devices that What's New Notice regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency use listing 15th April,2021 DCGI Message 202101 Jan 2021 For Medical devices which are under voluntary registrations, the file number generated is the Feb 15, 2021 · Medical Device Rules 2017 . Details of Standards followed by the company for product evaluation 13. 1800 11 1454 Sep 27, 2023 · Non-Notified Medical Devices: These devices do not need CDSCO’s approval and can be sold without specific regulatory checks. 2021 under the provisions of the Medical Device Rules, 2017 (Form MD-40 enclosed) The updated list of medical devices testing laboratories registered with CDSCO under the provisions of Medical Devices Rules, 2017 to carry out test or evaluation of a Mar 13, 2023 · Download the updated list of Medical Devices Testing Laboratories, the link is given below: The Central Drugs Standard Control Organisation (CDSCO) has approved two more Medical Device Testing Laboratories (MDTL) to carry out tests or evaluation of a medical device on behalf of the manufacturers under the provisions of the Medical Devices Rules Central Drugs Standard Control Organization (Medical Devices and Diagnostic Division) Medical Devices (MD) Frequently Asked Questions on Medical Device Rule, 2017 Doc No. 1800 11 1454 Title: General Hospital Medical Devices final list. Apr 13, 2017 · Directorate General Of Health Services Ministry of Health & Family Welfare, Government of India CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated 29. The medical devices are classified based on the intended use, risk associated with the device and other parameters specified in the first schedule of the Medical Devices Rules, 2017. Product Classification. List of FDC & New Drugs Approved For Marketing in India. Jul 12, 2021 · New Delhi: The apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has released the updated list of Medical Devices Testing Laboratories (MDTL), approving ten more MDTL to carry out tests or evaluation of medical devices on behalf of manufacturer registered with CDSCO under MDR 2017. 2020. -Gurgaon. List of approved Clinical Trial Sites and Investigators: 2019-Dec-02: 1932 KB: 3: List of approved Clinical Trial Sites & Investigators for Global Clinical Trials: 2019-Dec-02: 347 KB: 4: Notice regarding human vacine appliation through SUGAM online Portal of CDSCO: 2017-Dec-26: 584KB: 5: Notice Order regarding SUGAM ONLINE Dated 01. . 2017 under Drugs and Cosmetic Act to regulate the manufacture, import, sale and distribution of the medical devices and said rules are effective from 01. A-32, CDSCO updated list of Laboratories for conducting Performance Evaluation of In - Vitro Diagnostic Medical Device Sr. 2020 GSR 754 (E) 30-09-2022 Sale of Medical Device Directorate General Of Health Services Ministry of Health & Family Welfare, Government of India What's New Notice regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency use listing 15th April,2021 DCGI Message 202101 Jan 2021 For Medical devices which are under voluntary registrations, the file number generated is the Online System for Medical Devices Central Drugs Standard Control Organisation Directorate General Of Health Services Ministry of Health & Family Welfare, Government of India Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Directorate General of Health Services, Government of India FDA Bhavan, ITO, Kotla Road, New Delhi -110002; dci[at]nic[dot]in; 91-11-23236973; PRO Toll Free No. 2017 under Drugs and cosmetics Act to regulate the manufacture, import, sale and distribution of the medical devices and said rules are effective from 01. K: 2018-Aug-30: 72 KB: 381 Jan 13, 2021 · Note: Ultrasound devices will then likely require Import Licenses beginning November 1 st, 2021. Operating Room Shoe cover 4. Surgical Gown (Non-sterile) 2. Device Master File as per Annexure-VI for each category of device. Step 2 Appoint an India Authorized Agent to manage your device registration and interact with the CDSCO on your behalf. Instead of mandatory registration, these devices will now adhere to a licensing system outlined in GSR 102(E) dated 11. Nov 6, 2023 · PMA Approvals: Listings of all new or high-risk medical devices that were approved via the premarket approval (PMA) pathway. entries per page. A-32, Medical Devices Division, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. There are different types of application forms and the documentation requirements vary with the application form submitted to the CDSCO. Central Drugs Standard Control Organization (Medical Devices and Diagnostic Division) Medical Devices (MD) Frequently Asked Questions on Medical Device Rule, 2017 Doc No. Showing 1 to 10 of 43 entries. Jan 1, 2021 · What's New Notice regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency use listing 15th April,2021 DCGI Message 202101 Jan 2021 For Medical devices which are under voluntary registrations, the file number generated is the List of approved Clinical Trial Sites and Investigators: 2019-Dec-02: 1932 KB: 3: List of approved Clinical Trial Sites & Investigators for Global Clinical Trials: 2019-Dec-02: 347 KB: 4: Notice regarding human vacine appliation through SUGAM online Portal of CDSCO: 2017-Dec-26: 584KB: 5: Notice Order regarding SUGAM ONLINE Dated 01. 3. 02. New drugs approved by CDSCO is published under drugs@ CDSCO section. OF INDIA Notice: Renaming of Central Drugs Standard Control Organization dated 06. peajejt qad iulla mtvj heqzvc ttuca tscxnc cizbe xoes pblzfzh